John Thomas, Managing Director of Bonifacio Consulting’s Technical Practice, recently contributed an article to Medical Design & Outsourcing featuring work with Vascular Pathways. The article outlines a compelling case study of one company’s experience moving their contract manufacturing (CM) operations back to the United States. John details insightful lessons-learned from the experience, and tips that can help any medical device OEM who is considering a move to a new CM, or selecting their CM for the first time.
Here’s a sneak peek of the article:
Deciding where and how to manufacture a product is without a doubt one of the most important decisions a medical device OEM faces. This decision has many implications, from the overall successful manufacture of the product to the impact on the bottom line of the organization. To complicate matters, there are so many factors to be contemplated to ensure that a good manufacturing partner is selected, and once that manufacturing line is set, changing suppliers can be both challenging and expensive. One of the most common questions in any OEM’s mind is whether or not manufacturing on-shore or off-shore makes the most sense.
Vascular Pathways was a medical technology company focused on developing and commercializing novel vascular access devices via proprietary integrated nitinol guidewire technology. The company was growing and expanding their product line, but this presented problems in manufacturing. Their existing contract manufacturer (CM) in Tijuana wasn’t meeting production numbers with the current product line, and the company was cueing up the launch of their next generation product. At this critical point for the organization, Vascular Pathways was faced with the difficult decision of changing CM’s and also whether or not to bring manufacturing back to the U.S.